21 CFR Part 820 in English - We are an `In vitro? Medical Device European company

invitro_spain

Involved In Discussions
#1
21 CFR Part 820 in English - We are an `In vitro´ Medical Device European company

Hello all!

I have a silly question. We are an `In vitro´ medical device European company and I am going to prepare the 21 CFR 820 documents to Export to USA. We have the ISO 13485 certificate since 2009. All the Quality system documents and records are in spanish.

Must I prepare all documents and records in English for a future FDA inspection?

I don´t know how to do it. I´m afraid I have to maintain to QS in my company to do the same things.

Can anybody helps?

Thank you
 
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sagai

Quite Involved in Discussions
#2
Re: 21 CFR Part 820 in english?

Hi!
I do not know the exact and precise regulatory answer, but actually, i know a company having non english procedures and cleared their device in the US.
Regards
Szabolcs
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#3
Re: 21 CFR Part 820 in english?

Hello all!

I have a silly question. We are an `In vitro´ medical device European company and I am going to prepare the 21 CFR 820 documents to Export to USA. We have the ISO 13485 certificate since 2009. All the Quality system documents and records are in spanish.

Must I prepare all documents and records in English for a future FDA inspection?

I don´t know how to do it. I´m afraid I have to maintain to QS in my company to do the same things.

Can anybody helps?

Thank you
There is nothing that requires you to have it in English (that I know of, but I am not a Medical Device expert), but it might be a good idea since you want to do business in the States.

Just a suggestion and my simple opinion.
 

v9991

Trusted Information Resource
#4
Re: 21 CFR Part 820 in English - We are an `In vitro´ Medical Device European company

shouldn't the submission document be in english?
apart from dossiers there are certain QMS documentation which are relevant for annual submissions right? (complaints - recalls...(adverse events may not be relevant since its invitro device))....etc.,
 
M

MIREGMGR

#5
Re: 21 CFR Part 820 in English - We are an `In vitro´ Medical Device European company

The FDA operates internally and officially only in English. Submissions to them practically need to be in English.

Your QMS and design/production process can be in a language of your choice. However, if FDA inspects you, you will have to provide translations to English. This can be done on-the-spot, translating only those documents that are of interest to the Inspector.

Your product labeling of course is subject to FDA's English-except-if-marketed-only-where-some-other-language-is-predominant requirements.
 

invitro_spain

Involved In Discussions
#6
Re: 21 CFR Part 820 in English - We are an `In vitro´ Medical Device European company

Thank you very much to all for the information.

The important clue for me is that I can use the spanish for my QSR documents. It is clear the submission and the labeling must be in English.

I have to prepare technical documents and submission for export antibodies as ASR (Analyte Specific Reagents). For me it is the first time!

Any advice?

Thanks
 
I

Ironcountry

#7
Re: 21 CFR Part 820 in English - We are an `In vitro´ Medical Device European company

My company uses an ISO 13485 certified translation company.
 
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